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Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR).

NCT00878878 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-08-24

Study results available
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Summary

The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization for clinical reasons.

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)

Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose. Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.

DRUG

Dextrose

Arm A: Single intravenous (IV) injection of 0.5 mL Optison followed by single IV injection of 0.5 mL 5% dextrose. Arm B: Single IV injection of 0.5 mL 5% dextrose followed by single IV injection of 0.5 mL Optison.

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Christopher Jefferds · ICON Development Solutions

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00878878 on ClinicalTrials.gov